December 13, 2013 02:11 AM Eastern Standard Time
STOCKHOLM--(BUSINESS WIRE)--Regulatory News:
"These 6-month interim data are clearly promising and indicate very competitive performance of MOB-015"
Moberg Pharma AB (OMX:MOB)(STO:MOB) today announced positive interim results from its ongoing phase ll study of MOB-015. After six months of treatment with MOB-015, 40 per cent of the patients were mycologically cured and no safety concerns were identified. MOB-015 is a novel topical formulation of terbinafine for the treatment of nail fungus (onychomycosis).
The purpose of the study is to confirm the product concept of MOB-015 and provide a basis for out-licensing and further clinical development. 25 patients will be treated for twelve months and followed for a total of fifteen months with respect to the endpoints that the FDA and EMA normally accept for nail fungus. The primary endpoint is the proportion of patients with mycological cure, defined as negative culture and negative KOH microscopy. The study is conducted with leading expertise in the field at Sahlgrenska University Hospital in Gothenburg, Sweden. Patient enrollment in the study was completed in May 2013 and the final results are expected second half of 2014.
"These 6-month interim data are clearly promising and indicate very competitive performance of MOB-015", said Kjell Rensfeldt, VP R&D at Moberg Pharma.
"We are excited to announce the interim data for MOB-015. Oral terbinafine is the gold standard for the treatment of nail fungus. If the final data follow the trajectory of the interim results for this novel topical formulation, MOB-015 has the potential to become a major advance in the treatment of nail fungus", said Peter Wolpert, CEO of Moberg Pharma.
The results from the interim analysis are no guarantee that the final results at study completion will be positive.
About MOB-015 and nail fungus
MOB-015 is a new topical treatment for nail fungus. MOB-015 is based on Moberg Pharma's patent pending formulation technology, which in preclinical studies has been shown to transport high concentrations of terbinafine into and through nail tissue. As MOB-015 is applied locally, the safety issues associated with oral medications are avoided. Nail fungus is a common nail disease. It afflicts approximately 10 percent of the population and is more common among the elderly. The market is expected to exceed USD 1 billion. Many patients remain untreated and according to specialists in the field, there is a great need for a new topical treatment with a favorable safety profile.
About this information
Moberg Pharma discloses this information pursuant to the Swedish Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 8.00 am (CET) on December 13, 2013.
About Moberg Pharma
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with direct sales through its own sales organization in the US and sales through distributors in more than 40 countries. The company's product portfolio includes topical products for the treatment of skin disorders and pain under the brands Kerasal®, Jointflex®, Kerasal Nail™ and Kaprolac®. Kerasal Nail™ (Nalox™ in many markets) is the leading product for the treatment of nail disorders in the Nordic market. The portfolio is developed further through acquisitions and in-licensing of products as well as product development with focus on innovative drug delivery based on proven compounds. Moberg Pharma has offices in Stockholm and New Jersey and the company's share (OMX: MOB) is listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm. For further information, please visit: www.mobergpharma.com.
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For further information, please contact:
Peter Wolpert, CEO
Mobile: +46 (0)70 - 735 71 35
E-mail: [email protected] ([email protected])
Peter Östling, IR
Mobile: +46 (0)76 - 314 09 78
E-mail: [email protected]